Pharmacopeial Method Qualification Options

Discussions about methods, troubleshooting and best practices across both pharmaceutical and biopharmaceutical analysis.

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If a Drug Product didn't have a USP Monograph but one did exist in the EP, would the FDA accept an EP Method in a submission as long as it was appropriately qualified?
If I was still working, I'd sure push my boss and QA to accept that.

Many FDA regulations are too much of a gray area for my liking.
Latest Usp editions have the trend to remove various things, I recently found out that they removed an API and also it's ref std. So I changed to BP or EP or at least if there is any relevant iso method :roll:
3 posts Page 1 of 1

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